[Title 21 CFR 101.9]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 101 - FOOD LABELING]
[Subpart A - General Provisions]
[Sec. 101.9 - Nutrition labeling of food.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
2
1996-04-01
1996-04-01
false
Nutrition labeling of food.
101.9
Sec. 101.9
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
FOOD FOR HUMAN CONSUMPTION
FOOD LABELING
General Provisions
Sec. 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all
products intended for human consumption and offered for sale unless an
exemption is provided for the product in paragraph (j) of this section.
(1) When food is in package form, the required nutrition labeling
information shall appear on the label in the format specified in this
section.
(2) When food is not in package form, the required nutrition
labeling information shall be displayed clearly at the point of purchase
(e.g., on a counter card, sign, tag affixed to the product, or some
other appropriate device). Alternatively, the required information may
be placed in a booklet, looseleaf binder, or other appropriate
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format that is available at the point of purchase.
(3) Solicitation of requests for nutrition information by a
statement ``For nutrition information write to ________________'' on the
label or in the labeling or advertising for a food, or providing such
information in a direct written reply to a solicited or unsolicited
request, does not subject the label or the labeling of a food exempted
under paragraph (j) of this section to the requirements of this section
if the reply to the request conforms to the requirements of this
section.
(4) If any vitamin or mineral is added to a food so that a single
serving provides 50 percent or more of the Reference Daily Intake (RDI)
for the age group for which the product is intended, as specified in
paragraph (c)(8)(iv) of this section, of any one of the added vitamins
or minerals, unless such addition is permitted or required in other
regulations, e.g., a standard of identity or nutritional quality
guideline, or is otherwise exempted by the Commissioner, the food shall
be considered a food for special dietary use within the meaning of
Sec. 105.3(a)(1)(iii) of this chapter.
(b) Except as provided in Sec. 101.9(h)(3), all nutrient and food
component quantities shall be declared in relation to a serving as
defined in this section.
(1) The term ``serving'' or ``serving size'' means an amount of food
customarily consumed per eating occasion by persons 4 years of age or
older which is expressed in a common household measure that is
appropriate to the food. When the food is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the ``Reference Amounts Customarily Consumed Per Eating Occasion *
* *'' (reference amounts) that appear in Sec. 101.12(b) using the
procedures described below. For products that are both intended for
weight control and available only through a weight-control program, a
manufacturer may determine the serving size that is consistent with the
meal plan of the program. Such products must bear a statement, ``for
sale only through the -------- program'' (fill in the blank with the
name of the appropriate weight-control program, e.g., Smith's Weight
Control), on the principal display panel. However, the reference amounts
in Sec. 101.12(b) shall be used for purposes of evaluating whether
weight-control products that are available only through a weight-control
program qualify for nutrient content claims or health claims.
(i) For products in discrete units (e.g., muffins, sliced products,
such as sliced bread, or individually packaged products within a
multiserving package) and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is in discrete units
(e.g., pancakes and syrup), the serving size shall be declared as
follows:
(A) If a unit weighs 50 percent or less of the reference amount, the
serving size shall be the number of whole units that most closely
approximates the reference amount for the product category;
(B) If a unit weighs more than 50 percent, but less than 67 percent
of the reference amount, the manufacturer may declare one unit or two
units as the serving size;
(C) If a unit weighs 67 percent or more, but less than 200 percent
of the reference amount, the serving size shall be one unit;
(D) If a unit weighs 200 percent or more of the reference amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single-eating occasion.
(E) For products that have reference amounts of 100 grams (g) (or
milliliter (mL)) or larger and are individual units within a
multiserving package, if a unit contains more than 150 percent but less
than 200 percent of the reference amount, the manufacturer may
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decide whether to declare the individual unit as 1 or 2 servings.
(F) The serving size for maraschino cherries shall be expressed as 1
cherry with the parenthetical metric measure equal to the average weight
of a medium size cherry.
(G) The serving size for products that naturally vary in size (e.g.,
pickles, shellfish, whole fish, and fillet of fish) may be the amount in
ounces that most closely approximates the reference amount for the
product category. Manufacturers shall adhere to the requirements in
paragraph (b)(5)(vi) of this section for expressing the serving size in
ounces.
(H) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., pancakes and syrup), the
serving size may be the number of discrete units represented as the main
ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
(I) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(ii) For products in large discrete units that are usually divided
for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared
products where the entire contents of the package is used to prepare
large discrete units that are usually divided for consumption (e.g.,
cake mix, pizza kit), and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is a large discrete unit
usually divided for consumption (e.g., prepared cake packaged with a can
of frosting), the serving size shall be the fractional slice of the
ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
6 cabbage) that most closely approximates the reference amount for the
product category, and may be the fraction of the package used to make
the reference amount for the unprepared product determined in
Sec. 101.12(c) or the fraction of the large discrete unit represented as
the main ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/
4, 1/5, 1/6, or smaller fractions that can be generated by further
division by 2 or 3.
(iii) For nondiscrete bulk products (e.g., breakfast cereal, flour,
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese
kits), and for products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is a bulk product (e.g., peanut butter and jelly),
the serving size shall be the amount in household measure that most
closely approximates the reference amount for the product category and
may be the amount of the bulk product represented as the main ingredient
plus proportioned minor ingredients used to make the reference amount
for the combined product determined in Sec. 101.12(f).
(3) The serving size for meal products and main dish products as
defined in Sec. 101.13(l) and (m) that comes in single-serving
containers as defined in paragraph (b)(6) of this section shall be the
entire content (edible portion only) of the package. Serving size for
meal products and main dish products in multiserving containers shall be
based on the reference amount applicable to the product in
Sec. 101.12(b) if the product is listed in Sec. 101.12(b). Serving size
for meal products and main dish products in multiserving containers that
are not listed in Sec. 101.12(b) shall be based on the reference amount
according to Sec. 101.12(f).
(4) A variety pack, such as a package containing several varieties
of single-serving units as defined in paragraph (b)(2)(i) of this
section, and a product having two or more compartments with each
compartment containing a different food, shall provide nutrition
information for each variety or food per serving size that is derived
from the reference amount in Sec. 101.12(b) applicable for each variety
or food and
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the procedures to convert the reference amount to serving size in
paragraph (b)(2) of this section.
(5) For labeling purposes, the term ``common household measure'' or
``common household unit'' means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other
common household equipment used to package food products (e.g., jar,
tray). In expressing serving size in household measures, except as
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and
(b)(5)(vii) of this section, the following rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate except for beverages. For beverages, a manufacturer may
use fluid ounces. Cups shall be expressed in 1/4-or 1/3-cup increments,
tablespoons in whole number of tablespoons for quantities less than 1/4
cup but greater than or equal to 2 tablespoons (tbsp), 1, 1 1/3, 1 1/2,
or 1 2/3 tbsp for quantities less than 2 tbsp but greater than or equal
to 1 tbsp, and teaspoons in whole number of teaspoons for quantities
less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in
1/4-tsp increments for quantities less than 1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not
applicable, ounces may be used with an appropriate visual unit of
measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2
pickle). Ounce measurements shall be expressed in 0.5 oz increments most
closely approximating the reference amount.
(iv) A description of the individual container or package shall be
used for single serving containers and for individually packaged
products within multiserving containers (e.g., can, box, package). A
description of the individual unit shall be used for other products in
discrete units (e.g., piece, slice, cracker, bar).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., cake mix, pizza kit), the fraction or portion of the
package may be used.
(vi) Ounces with an appropriate visual unit of measure, as described
in paragraph (b)(5)(iii) of this section, may be used for products that
naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this
section.
(vii) As provided for in Sec. 101.9(h)(1), for products that consist
of two or more distinct ingredients or components packaged and presented
to be consumed together (e.g. dry macaroni and cheese mix, cake and
muffin mixes with separate ingredient packages, pancakes and syrup),
nutrition information may be declared for each component or as a
composite. The serving size may be provided in accordance with the
provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
section, or alternatively in ounces with an appropriate visual unit of
measure, as described in paragraph (b)(5)(iii) of this section (e.g.,
declared as separate components: ``3 oz dry macaroni (84 g/about 2/3
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a
composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry
cheese mix)'').
(viii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz
means 30 mL, and 1 oz in weight means 28 g.
(ix) When a serving size, determined from the reference amount in
Sec. 101.12(b) and the procedures described in this section, falls
exactly half way between two serving sizes, e.g., 2.5 tbsp,
manufacturers shall round the serving size up to the next incremental
size.
(6) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable reference amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving except for products that
have reference amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the reference amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
reference amount may be labeled as a single-serving if the entire
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content of the package can reasonably be consumed at a single-eating
occasion.
(7) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(6) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams) except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to
Sec. 101.9(b)(9). However, if a manufacturer voluntarily provides the
metric quantity on products that can be sold as single servings, then
the numerical value provided as part of the serving size declaration
must be identical to the metric quantity declaration provided as part of
the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce and fluid
ounce, in parenthesis, following the metric measure separated by a slash
where other common household measures are used as the primary unit for
serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce
quantity equivalent to the metric quantity should be expressed in 0.1 oz
increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for
fluid ounce.
(v) For products that only require the addition of water or another
ingredient that contains insignificant amounts of nutrients in the
amount added and that are prepared in such a way that there are no
significant changes to the nutrient profile, the amount of the finished
product may be declared in parentheses at the end of the serving size
declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup
prepared)).
(vi) To promote uniformity in label serving sizes in household
measures declared by different manufacturers, FDA has provided a
guideline entitled, ``Guidelines for Determining the Gram Weight of the
Household Measure.'' The guideline can be obtained from the Office of
Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
(8) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term ``about'' (e.g., about 2 servings,
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., maraschino cherries, pickles), the
manufacturer may state the typical number of servings per container
(e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the reference amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement.
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number
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of individual packages within the total package.
(v) For packages containing several individually packaged
multiserving units, the number of servings shall be determined by
multiplying the number of individual multiserving units in the total
package by the number of servings in each individual unit.
(9) The declaration of nutrient and food component content shall be
on the basis of food as packaged or purchased with the exception of raw
fish covered under Sec. 101.42 (see 101.44), packaged single-ingredient
products that consist of fish or game meat as provided for in paragraph
(j)(11) of this section, and of foods that are packed or canned in
water, brine, or oil but whose liquid packing medium is not customarily
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and
pickled vegetables). Declaration of nutrient and food component content
of raw fish shall follow the provisions in Sec. 101.45. Declaration of
the nutrient and food component content of foods that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(10) Another column of figures may be used to declare the nutrient
and food component information:
(i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as
packaged or purchased;
(ii) Per one unit if the serving size of a product in discrete units
in a multiserving container is more than 1 unit;
(iii) Per cup popped for popcorn in a multiserving container.
(11) If a product is promoted on the label, labeling, or advertising
for a use that differs in quantity by twofold or greater from the use
upon which the reference amount in Sec. 101.12(b) was based (e.g.,
liquid cream substitutes promoted for use with breakfast cereals), the
manufacturer shall provide a second column of nutrition information
based on the amount customarily consumed in the promoted use, in
addition to the nutrition information per serving derived from the
reference amount in Sec. 101.12(b), except that nondiscrete bulk
products that are used primarily as ingredients (e.g., flour,
sweeteners, shortenings, oils), or traditionally used for multipurposes
(e.g., eggs, butter, margarine), and multipurpose baking mixes are
exempt from this requirement.
(c) The declaration of nutrition information on the label and in
labeling of a food shall contain information about the level of the
following nutrients, except for those nutrients whose inclusion, and the
declaration of amounts, is voluntary as set forth in this paragraph. No
nutrients or food components other than those listed in this paragraph
as either mandatory or voluntary may be included within the nutrition
label. Except as provided for in paragraphs (f) or (j) of this section,
nutrient information shall be presented using the nutrient names
specified and in the following order in the formats specified in
paragraphs (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parentheses immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i. e., the Atwater method) given
in Table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L.
Merrill and B. K. Watt, United States Department of Agriculture (USDA)
Handbook No. 74 (slightly revised, 1973), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.;
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(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 (the availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA Handbook No. 74
(slightly revised 1973) pp. 9-11, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of
this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section;
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of this chapter, or by other means, as
appropriate; or
(E) Using bomb calorimetry data subtracting 1.25 calories per gram
protein to correct for incomplete digestibility, as described in USDA
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the
availability of this incorporation by reference is given in paragraph
(c)(1)(i)(A) of this section).
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section in
a serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat in a serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section. Except as provided for in paragraph (f) of this section, if
``Calories from fat'' is not required and, as a result, not declared,
the statement ``Not a significant source of calories from fat'' shall be
placed at the bottom of the table of nutrient values in the same type
size.
(iii) ``Calories from saturated fat'' or ``Calories from saturated''
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section in a serving may
be declared voluntarily, expressed to the nearest 5-calorie increment,
up to and including 50 calories, and the nearest 10-calorie increment
above 50 calories, except that amounts less than 5 calories may be
expressed as zero. This statement shall be indented under the statement
of calories from fat as provided in paragraph (d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat in a serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (1/2) gram increment below 5 grams and to the nearest gram increment
above 5 grams. If the serving contains less than 0.5 gram, the content
shall be expressed as zero.
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of saturated fat in a serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat in a serving if no claims are
made about fat or cholesterol content, and if ``calories from saturated
fat'' is not declared. Except as provided for in paragraph (f) of this
section, if a statement of the saturated fat content is not required
and, as a result, not declared, the statement ``Not a significant source
of saturated fat'' shall be placed at the bottom of the table of
nutrient values in the same type size. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 (1/2)
gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat in a serving
defined as cis,cis-methylene-interrupted
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polyunsaturated fatty acids may be declared voluntarily, except that
when monounsaturated fat is declared, or when a claim about fatty acids
or cholesterol is made on the label or in labeling of a food other than
one that meets the criteria in Sec. 101.62(b)(1) for a claim for ``fat
free,'' label declaration of polyunsaturated fat is required.
Polyunsaturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat in a serving
defined as cis-monounsaturated fatty acids may be declared voluntarily
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a food
other than one that meets the criteria in Sec. 101.62(b)(1) for a claim
for ``fat free,'' label declaration of monounsaturated fat is required.
Monounsaturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content in a
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams cholesterol in a
serving and make no claim about fat, fatty acids, or cholesterol
content, or such products may state the cholesterol content as zero.
Except as provided for in paragraph (f) of this section, if cholesterol
content is not required and, as a result, not declared, the statement
``Not a significant source of cholesterol'' shall be placed at the
bottom of the table of nutrient values in the same type size. If the
food contains 2 to 5 milligrams of cholesterol per serving, the content
may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium in
a specified serving of food expressed as zero when the serving contains
less than 5 milligrams of sodium, to the nearest 5-milligram increment
when the serving contains 5 to 140 milligrams of sodium, and to the
nearest 10-milligram increment when the serving contains greater than
140 milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium in a specified serving of food may be declared
voluntarily, except that when a claim is made about potassium content,
label declaration shall be required. Potassium content shall be
expressed as zero when the serving contains less than 5 milligrams of
potassium, to the nearest 5-milligram increment when the serving
contains less than or equal to 140 milligrams of potassium, and to the
nearest 10-milligram increment when the serving contains more than 140
milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate in a serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the food. This
calculation method is described in A. L. Merrill and B. K. Watt,
``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 74
(slightly revised 1973) pp. 2 and 3, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability
of this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section).
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber in a serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5
[[Page 30]]
gram, the content may be expressed as zero. Except as provided for in
paragraph (f) of this section, if dietary fiber content is not required
and as a result, not declared, the statement ``Not a significant source
of dietary fiber'' shall be placed at the bottom of the table of
nutrient values in the same type size.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber in a serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber in a serving may be declared
voluntarily except that when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble
fiber content shall be indented under dietary fiber and expressed to the
nearest gram except that if a serving contains less than 1 gram, the
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be
used as an alternative, and if the serving contains less than 0.5 gram,
the content may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars in a
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars in a serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Except as provided for in paragraph (f) of this section, if a statement
of the sugars content is not required and, as a result, not declared,
the statement ``Not a significant source of sugars'' shall be placed at
the bottom of the table of nutrient values in the same type size. Sugars
shall be defined as the sum of all free mono- and disaccharides (such as
glucose, fructose, lactose, and sucrose). Sugars content shall be
indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less then 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols in a serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
food, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of
the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the food may be used in the nutrition
label provided that only one sugar alcohol is present in the food. Sugar
alcohol content shall be indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less then 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrates may be declared voluntarily. Other
carbohydrates shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less
than 1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
[[Page 31]]
(7) ``Protein'': A statement of the number of grams of protein in a
serving, expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in foods represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a food represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement ``not a significant source of protein,'' or a
listing aligned under the column headed ``Percent Daily Value'' of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as Percent of Daily Value. When the protein
quality in a food as measured by the Protein Efficiency Ratio (PER) is
less than 40 percent of the reference standard (casein) for a food
represented or purported to be for infants, the statement ``not a
significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by the appropriate method of analysis as given in the
``Official Methods of Analysis of the AOAC International'' (formerly the
Association of Official Analytical Chemists), 15th Ed. (1990), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, except when the official procedure for a specific food requires
another factor. Copies may be obtained from AOAC, 2200 Wilson Blvd.,
suite 400, Arlington, VA 22201-3301, or may be inspected at the Office
of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as Percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for use by infants
or children under 4 years of age. When such a declaration is provided,
it shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed ``Percent Daily Value,'' and
expressed to the nearest whole percent. However, the percentage of the
RDI for protein shall not be declared if the food is represented or
purported to be for use by infants and the protein quality value is less
than 40 percent of the reference standard.
(ii) The ``corrected amount of protein (gram) per serving'' for
foods represented or purported for adults and children 1 or more years
of age is equal to the actual amount of protein (gram) per serving
multiplied by the amino acid score corrected for protein digestibility.
If the corrected score is above 1.00, then it shall be set at 1.00. The
protein digestibility-corrected amino acid score shall be determined by
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation,'' Rome, 1990, except that when official AOAC
procedures described in section (c)(7) of this paragraph require a
specific food factor other than 6.25, that specific factor shall be
used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation'' as published by the Food and Agriculture
Organization of the United Nations/World Health Organization is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-150), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
[[Page 32]]
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
For foods represented or purported for infants, the corrected amount of
protein (grams) per serving is equal to the actual amount of protein
(grams) per serving multiplied by the relative protein quality value.
The relative protein quality value shall be determined by dividing the
subject food protein PER value by the PER value for casein. If the
relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the Daily
Reference Value (DRV) or RDI, a value of 50 grams of protein shall be
the DRV for adults and children 4 or more years of age, and the RDI for
protein for children less than 4 years of age, infants, pregnant women,
and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams,
respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d), (e), and (f) of this section, foods
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For foods represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on foods represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other foods shall use
the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added as a
nutrient supplement, or when a claim is made about them. Other vitamins
and minerals need not be declared if neither the nutrient nor the
component is otherwise referred to on the label or in labeling or
advertising and the vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another food; or
(B) Included in a food solely for technological purposes and
declared only in the ingredient statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients).'' Alternatively, except as provided for in
paragraph (f) of this section, if vitamin A, vitamin C, calcium, or iron
is present in amounts less than 2 percent of the RDI, label declaration
of the nutrient(s) is not required if the statement ``Not a significant
source of __________ (listing the vitamins or minerals omitted)'' is
placed
[[Page 33]]
at the bottom of the table of nutrient values. Either statement shall be
in the same type size as nutrients that are indented.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams
(v) The following synonyms may be added in parentheses immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--either Folic acid or Folacin may be used.
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent DV of
vitamin A in the food (e.g., ``Percent Daily Value: Vitamin A 50 (90
percent as beta-carotene)''). When declared, the percentages shall be
expressed in the same increments as are provided for vitamins and
minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Unit of
Food component measurement DRV
------------------------------------------------------------------------
Fat............................. gram (g).......... 65
Saturated fatty acids........... do................ 20
Cholesterol..................... milligrams (mg)... 300
Total carbohydrate.............. grams (g)......... 300
Fiber........................... do................ 25
Sodium.......................... milligrams (mg)... 2,400
Potassium....................... do................ 3,500
Protein......................... grams (g)......... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on foods in the following format, as shown in
paragraph (d)(12) of this section, except on foods on which dual columns
of nutrition information are declared as provided for in paragraph (e)
of this section, on those food products on which the simplified format
is required to be used as provided for in paragraph (f) of this section,
on foods for infants and children less than 4 years of age as provided
for in paragraph (j)(5) of this section, and on foods in small or
intermediate-sized packages as provided for in paragraph (j)(13) of this
section. In the interest of uniformity of presentation, FDA urges that
the nutrition information be presented using the graphic specifications
set forth in appendix B to part 101.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section as
shown in paragraph (d)(12), and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the
[[Page 34]]
heading ``Nutrition Facts,'' the information required in paragraphs
(d)(4), (d)(6), and (d)(9) of this section and all other information
contained within the nutrition label shall be in type size no smaller
than 6 point. When provided, the information described in paragraph
(d)(10) of this section shall also be in type no smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total
Carbohydrate,'' and ``Protein''), and the percentage amounts required by
paragraph (d)(7)(ii) of this section shall be highlighted by bold or
extra bold type or other highlighting (reverse printing is not permitted
as a form of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate ``Amount Per Serving'' from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent Daily Value required in paragraphs (d)(7)(i)
and (d)(7)(ii) of this section from the nutrient and percent Daily Value
above and below it, as shown in paragraph (d)(12) of this section.
(2) The information shall be presented under the identifying heading
of ``Nutrition Facts'' which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section, as shown in
paragraph (d)(12) of this section.
(3) Information on serving size shall immediately follow the heading
as shown in paragraph (d)(12) of this section. Such information shall
include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(7) of this section.
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single serving
containers as defined in paragraph (b)(6) of this section or on other
food containers when this information is stated in the net quantity of
contents declaration.
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar as shown in paragraph (d)(12) of this
section.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g., ``% Daily Value*''), shall be separated from information on
calories by a bar as shown in paragraph (d)(12) of this section. The
position of this column heading shall allow for a list of nutrient names
and amounts as described in paragraph (d)(7) of this section to be to
the left of, and below, this column heading. The column headings
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted
for ``% Daily Value.''
(7) Except as provided for in paragraph (j)(13) of this section,
nutrient information for both mandatory and any voluntary nutrients
listed in paragraph (c) of this section that are to be declared in the
nutrition label, except vitamins and minerals, shall be declared as
follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and followed immediately by the
quantitative amount by weight for that nutrient appended with a ``g''
for grams or ``mg'' for milligrams as shown in paragraph (d)(12) of this
section.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established
[[Page 35]]
in paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column described
in paragraph (d)(7)(i) of this section for which a DRV has been
established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns as shown in paragraph (d)(12)
of this section, except that when more than four vitamins and minerals
are declared, they may be declared vertically with percentages listed
under the column headed ``% Daily Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state:
Percent Daily Values are based on a 2,000 calorie diet.
Your daily values may be higher or lower depending on your calorie
needs.
------------------------------------------------------------------------
Calories: 2,000 2,500
------------------------------------------------------------------------
Total fat..................... Less than..... 65 g 80 g
Saturated fat................. Less than..... 20 g 25 g
Cholesterol................... Less than..... 300 mg 300 mg
Sodium........................ Less than..... 2,400 mg 2,400 mg
Total carbohydrate............ .............. 300 g 375 g
Dietary fiber................. .............. 25 g 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and a value of 65 g in the column headed ``2,500''.
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (j)(13)(ii)(B) of
this section may be used within the footnote.
(10) Caloric conversion information on a per gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9) of this section, separated from that
information by a hairline. This information may be presented
horizontally as shown in paragraph (d)(12) of this section (i.e.,
``Calories per gram: fat 9, carbohydrate 4, protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent Daily Value information. The caloric
conversion information provided for in paragraph (d)(10) of this section
may be presented beneath either side or along the full length of the
nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the nutrients and
the percent DV information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 in) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display as shown
below.
[[Page 36]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.351
[[Page 37]]
(12) The following sample label illustrates the provisions of
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR01JA93.352
[[Page 38]]
(13)(i) Nutrition labels on the outer label of packages of products
that contain two or more separately packaged foods that are intended to
be eaten individually (e.g., variety packs of cereals or snack foods) or
of packages that are used interchangeably for the same type of food
(e.g., round ice cream containers) may use an aggregate display.
(ii) Aggregate displays shall comply with the format requirements of
paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified immediately under the
``Nutrition Facts'' title, and both the quantitative amount by weight
(i.e., g/mg amounts) and the percent Daily Value for each nutrient shall
be listed in separate columns under the name of each food. The following
sample label illustrates an aggregate display.
[GRAPHIC] [TIFF OMITTED] TR01JA93.353
(14) In accordance with Sec. 101.15(c)(2), when nutrition labeling
must appear in a second language, the nutrition information may be
presented in a separate nutrition label for each language or in one
nutrition label with the information in the second language following
that in English. Numeric characters that are identical in both languages
need not be repeated (e.g., ``Protein/Proteinas 2 g''). All required
information must be included in both languages.
(e) Nutrition information may be presented for two or more forms of
the same food (e.g., both ``as purchased'' and ``as prepared'') or for
common combinations of food as provided for in paragraph (h)(4) of this
section, for different units (e.g., slices of bread or per
[[Page 39]]
100 grams) as provided for in paragraph (b) of this section, or for two
or more groups for which RDI's are established (e.g., both infants and
children less than 4 years of age) as shown in paragraph (e)(5) of this
section. When such dual labeling is provided, equal prominence shall be
given to both sets of values. Information shall be presented in a format
consistent with paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same food (e.g., ``Mix'' and ``Baked''), the combinations of food, the
units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the reference amount in Sec. 101.12(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same food, for combinations of food, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
reference amount in Sec. 101.12(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the reference amount in Sec. 101.12(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this
section shall be presented under the subheading ``% DAILY VALUE'' and in
columns directly under the column headings set forth in paragraph (e)(1)
of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 40]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.354
(f) The declaration of nutrition information may be presented in the
simplified format set forth herein when a food product contains
insignificant amounts of seven or more of the following: Calories, total
fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary
fiber, sugars, protein,
[[Page 41]]
vitamin A, vitamin C, calcium, and iron; except that for foods intended
for children less than 2 years of age to which Sec. 101.9(j)(5)(i)
applies, nutrition information may be presented in the simplified format
when a food product contains insignificant amounts of six or more of the
following: Calories, total fat, sodium, total carbohydrate, dietary
fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.
(1) An ``insignificant amount'' shall be defined as that amount that
allows a declaration of zero in nutrition labeling, except that for
total carbohydrate, dietary fiber, and protein, it shall be an amount
that allows a declaration of ``less than 1 gram.''
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, protein, and
sodium;
(ii) Calories from fat and any other nutrients identified in
paragraph (f) of this section that are present in the food in more than
insignificant amounts; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are required to be added as a nutrient supplement
to foods for which a standard of identity exists.
(iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this
section voluntarily added to the food as nutrient supplements.
(3) Other nutrients that are naturally present in the food in more
than insignificant amounts may be voluntarily declared as part of the
simplified format.
(4) If any nutrients are declared as provided in paragraphs
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the
simplified format or if any nutrition claims are made on the label or in
labeling, the statement ``Not a significant source of ----------'' (with
the blank filled in with the name(s) of any nutrient(s) identified in
Sec. 101.9(f) and calories from fat that are present in insignificant
amounts) shall be included at the bottom of the nutrition label.
(5) Except as provided for in paragraphs (j)(5) and (j)(13) of this
section, nutrient information declared in the simplified format shall be
presented in the same manner as specified in paragraphs (d) or (e) of
this section, except that the footnote required in paragraph (d)(9) of
this section is not required. When the footnote is omitted, an asterisk
shall be placed at the bottom of the label followed by the statement
``Percent Daily Values are based on a 2,000 calorie diet'' and, if the
term ``Daily Value'' is not spelled out in the heading, a statement that
``DV'' represents ``Daily Value.''
(g) Compliance with this section shall be determined as follows:
(1) A collection of primary containers or units of the same size,
type, and style produced under conditions as nearly uniform as possible,
designated by a common container code or marking, or in the absence of
any common container code or marking, a day's production, constitutes a
``lot.''
(2) The sample for nutrient analysis shall consist of a composite of
12 subsamples (consumer units), taken 1 from each of 12 different
randomly chosenshipping cases, to be representative of a lot. Unless a
particular method of analysis is specified in paragraph (c) of this
section, composites shall be analyzed by appropriate methods as given in
the ``Official Methods of Analysis of the AOAC International,'' 15th Ed.
(1990), which is incorporated by reference in accordance with 5 U.S.C.
552(a) or 1 CFR part 51 or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
The availability of this incorporation by reference is given in
paragraph (c)(7) of this section.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any
ingredient which contains a naturally occurring (indigenous) nutrient is
added to a food, the total amount of such nutrient in the final food
product is subject to class II requirements unless the same nutrient is
also added.
(4) A food with a label declaration of a vitamin, mineral, protein,
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated
or monounsaturated fat, or potassium shall be deemed to be misbranded
under section 403(a) of the Federal
[[Page 42]]
Food, Drug, and Cosmetic Act (the act) unless it meets the following
requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium.
The nutrient content of the composite is at least equal to the value for
that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium. The nutrient content of the composite is at least equal to 80
percent of the value for that nutrient declared on the label.
Provided, That no regulatory action will be based on a determination
of a nutrient value that falls below this level by a factor less than
the variability generally recognized for the analytical method used in
that food at the level involved.
(5) A food with a label declaration of calories, sugars, total fat,
saturated fat, cholesterol, or sodium shall be deemed to be misbranded
under section 403(a) of the act if the nutrient content of the composite
is greater than 20 percent in excess of the value for that nutrient
declared on the label. Provided, That no regulatory action will be based
on a determination of a nutrient value that falls above this level by a
factor less than the variability generally recognized for the analytical
method used in that food at the level involved.
(6) Reasonable excesses of a vitamin, mineral, protein, total
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or
monounsaturated fat, or potassium over labeled amounts are acceptable
within current good manufacturing practice. Reasonable deficiencies of
calories, sugars, total fat, saturated fat, cholesterol, or sodium under
labeled amounts are acceptable within current good manufacturing
practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) Compliance with the provisions set forth in paragraphs (g)(1)
through (g)(6) of this section may be provided by use of an FDA approved
data base that has been computed following FDA guideline procedures and
where food samples have been handled in accordance with current good
manufacturing practice to prevent nutrition loss. FDA approval of a data
base shall not be considered granted until the Center for Food Safety
and Applied Nutrition has agreed to all aspects of the data base in
writing. The approval will be granted where a clear need is presented
(e.g., raw produce and seafood). Approvals will be in effect for a
limited time, e.g., 10 years, and will be eligible for renewal in the
absence of significant changes in agricultural or industry practices.
Approval requests shall be submitted in accordance with the provisions
of Sec. 10.30 of this chapter. Guidance in the use of data bases may be
found in the ``FDA Nutrition Labeling Manual--A Guide for Developing and
Using Data Bases,'' available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(9) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section (e.g., to develop adequate nutrient
profiles to comply with the requirements of paragraph (c) of this
section), FDA may permit alternative means of compliance or additional
exemptions to deal with the situation. Firms in need of such special
allowances shall make their request in writing to the Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204.
(h) Products with separately packaged ingredients or foods, with
assortments of food, or to which other ingredients are added by the user
may be labeled as follows:
(1) If a product consists of two or more separately packaged
ingredients enclosed in an outer container or of assortments of the same
type of food (e.g., assorted nuts or candy mixtures) in the same retail
package, nutrition labeling shall be located on the outer container or
retail package (as the case may be) to provide information for the
consumer at the point of purchase. However, when two or more food
products are simply combined together in such a manner that no outer
container is used, or no outer label is available,
[[Page 43]]
each product shall have its own nutrition information, e.g., two boxes
taped together or two cans combined in a clear plastic overwrap. When
separately packaged ingredients or assortments of the same type of food
are intended to be eaten at the same time, the nutrition information may
be specified per serving for each component or as a composite value.
(2) If a product consists of two or more separately packaged foods
that are intended to be eaten individually and that are enclosed in an
outer container (e.g., variety packs of cereals or snack foods), the
nutrition information shall:
(i) Be specified per serving for each food in a location that is
clearly visible to the consumer at the point of purchase; and
(ii) Be presented in separate nutrition labels or in one aggregate
nutrition label with separate columns for the quantitative amount by
weight and the percent Daily Value for each food.
(3) If a package contains a variety of foods, or an assortment of
foods, and is in a form intended to be used as a gift, the nutrition
labeling shall be in the form required by paragraphs (a) through (f) of
this section, but it may be modified as follows:
(i) Nutrition information may be presented on the label of the outer
package or in labeling within or attached to the outer package.
(ii) In the absence of a reference amount customarily consumed in
Sec. 101.12(b) that is appropriate for the variety or assortment of
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may
be used as the standard serving size for purposes of nutrition labeling
of foods subject to this paragraph. However, the reference amounts
customarily consumed in Sec. 101.12(b) shall be used for purposes of
evaluating whether individual foods in a gift package qualify for
nutrient content claims or health claims.
(iii) The number of servings per container may be stated as
``varied.''
(iv) Nutrition information may be provided per serving for
individual foods in the package, or, alternatively, as a composite per
serving for reasonable categories of foods in the package having similar
dietary uses and similar significant nutritional characteristics.
Reasonable categories of foods may be used only if accepted by FDA. In
determining whether a proposed category is reasonable, FDA will consider
whether the values of the characterizing nutrients in the foods proposed
to be in the category meet the compliance criteria set forth in
paragraphs (g)(3) through (g)(6) of this section. Proposals for such
categories may be submitted in writing to the Office of Food Labeling
(HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(v) If a food subject to paragraph (j)(13) of this section because
of its small size is contained in a gift package, the food need not be
included in the determination of nutrition information under paragraph
(h) of this section if it is not specifically listed in a promotional
catalogue as being present in the gift package, and:
(A) It is used in small quantities primarily to enhance the
appearance of the gift package; or
(B) It is included in the gift package as a free gift or promotional
item.
(4) If a food is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare nutrition information on the basis of the food as
consumed in the format required in paragraph (e) of this section (e.g.,
a dry ready-to-eat cereal may be described with one set of Percent Daily
Values for the cereal as sold (e.g., per ounce), and another set for the
cereal and milk as suggested in the label (e.g., per ounce of cereal and
1/2 cup of vitamin D fortified skim milk); and a cake mix may be labeled
with one set of Percent Daily Values for the dry mix (per serving) and
another set for the serving of the final cake when prepared): Provided,
That, the type and quantity of the other ingredients to be added to the
product by the user and the specific method of cooking and other
preparation shall be specified prominently on the label.
[[Page 44]]
(i) Except as provided in paragraphs (j)(13) and (j)(17) of this
section, the location of nutrition information on a label shall be in
compliance with Sec. 101.2.
(j) The following foods are exempt from this section or are subject
to special labeling requirements:
(1)(i) Food offered for sale by a manufacturer, packer, or
distributor who has annual gross sales made or business done in sales to
consumers that is not more than $500,000 or has annual gross sales made
or business done in sales of food to consumers of not more than $50,000,
Provided, That the food bears no nutrition claims or other nutrition
information in any context on the label or in labeling or advertising.
Claims or other nutrition information subject the food to the provisions
of this section.
(ii) For purposes of this paragraph, calculation of the amount of
sales shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years,
reasonable estimates must indicate that annual sales will not exceed the
amounts specified. For foreign firms that ship foods into the United
States, the business activities to be included shall be the total amount
of food sales, as well as other sales to consumers, by the firm in the
United States.
(2) Food products which are:
(i) Served in restaurants, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(ii) Served in other establishments in which food is served for
immediate human consumption (e.g., institutional food service
establishments, such as schools, hospitals, and cafeterias;
transportation carriers, such as trains and airplanes; bakeries,
delicatessens, and retail confectionery stores where there are
facilities for immediate consumption on the premises; food service
vendors, such as lunch wagons, ice cream shops, mall cookie counters,
vending machines, and sidewalk carts where foods are generally consumed
immediately where purchased or while the consumer is walking away,
including similar foods sold from convenience stores; and food delivery
systems or establishments where ready-to-eat foods are delivered to
homes or offices), Provided, That the food bears no nutrition claims or
other nutrition information in any context on the label or in labeling
or advertising. Claims or other nutrition information subject the food
to the provisions of this section;
(iii) Sold only in such facilities, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(iv) Used only in such facilities and not served to the consumer in
the package in which they are received (e.g., foods that are not
packaged in individual serving containers); or
(v) Sold by a distributor who principally sells food to such
facilities: Provided, That:
(A) This exemption shall not be available for those foods that are
manufactured, processed, or repackaged by that distributor for sale to
any persons other than restaurants or other establishments that serve
food for immediate human consumption, and
(B) The manufacturer of such products is responsible for providing
the nutrition information on the products if there is a reasonable
possibility that the product will be purchased directly by consumers.
(3) Food products that are:
(i) Of the type of food described in paragraphs (j)(2)(i) and
(j)(2)(ii) of this section,
(ii) Ready for human consumption,
(iii) Offered for sale to consumers but not for immediate human
consumption,
(iv) Processed and prepared primarily in a retail establishment, and
(v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by
independent delicatessens, bakeries, or retail confectionery stores
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service
food bars such as salad bars), Provided, That the food bears no
nutrition
[[Page 45]]
claims or other nutrition information in any context on the label or in
labeling or advertising. Claims or other nutrition information subject
the food to the provisions of this section.
(4) Foods that contain insignificant amounts of all of the nutrients
and food components required to be included in the declaration of
nutrition information under paragraph (c) of this section, Provided,
That the food bears no nutrition claims or other nutrition information
in any context on the label or in labeling or advertising. Claims or
other nutrition information subject the food to the provisions of this
section. An insignificant amount of a nutrient or food component shall
be that amount that allows a declaration of zero in nutrition labeling,
except that for total carbohydrate, dietary fiber, and protein, it shall
be an amount that allows a declaration of ``less than 1 gram.'' Foods
that are exempt under this paragraph include coffee beans (whole or
ground), tea leaves, plain unsweetened instant coffee and tea,
condiment-type dehydrated vegetables, flavor extracts, and food colors.
(5)(i) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 2 years of age shall
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and
except that such labeling shall not include calories from fat (paragraph
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)),
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)),
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
(ii) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 4 years of age shall
bear nutrition labeling, except that:
(A) Such labeling shall not include declarations of percent of Daily
Value for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber;
(B) Nutrient names and quantitative amounts by weight shall be
presented in two separate columns.
(C) The heading ``Percent Daily Value'' required in paragraph (d)(6)
of this section shall be placed immediately below the quantitative
information by weight for protein;
(D) Percent of Daily Value for protein, vitamins, and minerals shall
be listed immediately below the heading ``Percent Daily Value''; and
(E) Such labeling shall not include the footnote specified in
paragraph (d)(9) of this section.
(6) Dietary supplements of vitamins or minerals that have an RDI as
established in paragraph (c)(8)(iv) of this section or a DRV as
established in paragraph (c)(9) of this section shall be labeled in
compliance with Sec. 101.36, except that dietary supplements of vitamins
or minerals in food in conventional form (e.g., breakfast cereals), of
herbs, and of other similar nutritional substances shall conform to the
labeling of this section.
(7) Infant formula subject to section 412 of the act, as amended,
except that such foods shall be labeled in compliance with part 107 of
this chapter.
(8) Medical foods as defined in section 5(b) of the Orphan Drug Act
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to
be consumed or administered enterally under the supervision of a
physician and which is intended for the specific dietary management of a
disease or condition for which distinctive nutritional requirements,
based on recognized scientific principles, are established by medical
evaluation. A food is subject to this exemption only if:
(i) It is a specially formulated and processed product (as opposed
to a naturally occurring foodstuff used in its natural state) for the
partial or exclusive feeding of a patient by means of oral intake or
enteral feeding by tube;
(ii) It is intended for the dietary management of a patient who,
because of therapeutic or chronic medical needs, has limited or impaired
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or
certain nutrients, or who has other special medically determined
nutrient requirements, the dietary management of which cannot be
achieved by the modification of the normal diet alone;
(iii) It provides nutritional support specifically modified for the
management of the unique nutrient needs that
[[Page 46]]
result from the specific disease or condition, as determined by medical
evaluation;
(iv) It is intended to be used under medical supervision; and
(v) It is intended only for a patient receiving active and ongoing
medical supervision wherein the patient requires medical care on a
recurring basis for, among other things, instructions on the use of the
medical food.
(9) Food products shipped in bulk form that are not for distribution
to consumers in such form and that are for use solely in the manufacture
of other foods or that are to be processed, labeled, or repacked at a
site other than where originally processed or packed.
(10) Raw fruits, vegetables, and fish subject to section 403(q)(4)
of the act, except that the labeling of such foods should adhere to
guidelines in Sec. 101.45. This exemption is contingent on the food
bearing no nutrition claims or other nutrition information in any
context on the label or in labeling or advertising. Claims or other
nutrition information subject the food to nutrition labeling in
accordance with Sec. 101.45. The term ``fish'' includes freshwater or
marine fin fish, crustaceans, and mollusks, including shellfish,
amphibians, and other forms of aquatic animal life.
(11) Packaged single-ingredient products that consist of fish or
game meat (i.e., animal products not covered under the Federal Meat
Inspection Act or the Poultry Products Inspection Act, such as flesh
products from deer, bison, rabbit, quail, wild turkey, or ostrich)
subject to this section may provide required nutrition information for a
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis),
except that:
(i) Such products that make claims that are based on values as
packaged must provide nutrition information on an as packaged basis, and
(ii) Nutrition information is not required for custom processed fish
or game meats.
(12) Game meats (i.e., animal products not covered under the Federal
Meat Inspection Act or the Poultry Products Inspection Act, such as
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich)
may provide required nutrition information on labeling in accordance
with the provisions of paragraph (a)(2) of this section.
(13)(i) Foods in small packages that have a total surface area
available to bear labeling of less than 12 square inches, Provided, That
the labels for these foods bear no nutrition claims or other nutrition
information in any context on the label or in labeling or advertising.
Claims or other nutrition information subject the food to the provisions
of this section.
(A) The manufacturer, packer, or distributor shall provide on the
label of packages that qualify for and use this exemption an address or
telephone number that a consumer can use to obtain the required
nutrition information (e.g., ``For nutrition information, call 1-800-
123-4567'').
(B) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in type size no smaller than 6 point
or all uppercase type of 1/16 inches minimum height, except that
individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, may comply with Sec. 101.2(c)(5).
(ii) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) and (i) of this section by one or more of the
following means:
(A) Presenting the required nutrition information in a tabular or,
as provided below, linear (i.e., string) fashion rather than in vertical
columns if the product has a total surface area available to bear
labeling of less than 12 square inches, or if the product has a total
surface area available to bear labeling of 40 or less square inches and
the package shape or size cannot accommodate a standard vertical column
or tabular display on any label panel. Nutrition information may be
given in a linear fashion only if the label will not accommodate a
tabular display.
(1) The following sample label illustrates the tabular display.
[[Page 47]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.355
(2) The following sample label illustrates the linear display. When
nutrition information is given in a linear fashion, bolding is required
only on the title ``Nutrition Facts`` and is allowed voluntarily for the
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR01JA93.356
(B) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(C) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label followed
by the statement ``Percent Daily Values are based on a 2,000 calorie
diet`` and, if the term ``Daily Value'' is not spelled out in the
heading, a statement that ``DV'' represents ``Daily Value.''
(D) Presenting the required nutrition information on any label
panel.
(14) Shell eggs packaged in a carton that has a top lid designed to
conform to the shape of the eggs are exempt from outer carton label
requirements where the required nutrition information is clearly
presented immediately beneath the carton lid or in an insert that can be
clearly seen when the carton is opened.
(15) The unit containers in a multiunit retail food package where:
(i) The multiunit retail food package labeling contains all
nutrition information in accordance with the requirements of this
section;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in
height, except that this statement shall not be required when the inner
unit containers
[[Page 48]]
bear no labeling at all. The word ``individual'' may be used in lieu of
or immediately preceding the word ``Retail'' in the statement.
(16) Food products sold from bulk containers: Provided, That
nutrition information required by this section be displayed to consumers
either on the labeling of the bulk container plainly in view or in
accordance with the provisions of paragraph (a)(2) of this section.
(17) Foods in packages that have a total surface area available to
bear labeling greater than 40 square inches but whose principal display
panel and information panel do not provide sufficient space to
accommodate all required information may use any alternate panel that
can be readily seen by consumers for the nutrition label. The space
needed for vignettes, designs, and other nonmandatory label information
on the principal display panel may be considered in determining the
sufficiency of available space on the principal display panel for the
placement of the nutrition label. Nonmandatory label information on the
information panel shall not be considered in determining the sufficiency
of available space for the placement of the nutrition label.
(k) A food labeled under the provisions of this section shall be
deemed to be misbranded under sections 201(n) and 403(a) of the act if
its label or labeling represents, suggests, or implies:
(1) That the food, because of the presence or absence of certain
dietary properties, is adequate or effective in the prevention, cure,
mitigation, or treatment of any disease or symptom. Information about
the relationship of a dietary property to a disease or health-related
condition may only be provided in conformance with the requirements of
Sec. 101.14 and part 101, subpart E.
(2) That a balanced diet of ordinary foods cannot supply adequate
amounts of nutrients.
(3) That the lack of optimum nutritive quality of a food, by reason
of the soil on which that food was grown, is or may be responsible for
an inadequacy or deficiency in the quality of the daily diet.
(4) That the storage, transportation, processing, or cooking of a
food is or may be responsible for an inadequacy or deficiency in the
quality of the daily diet.
(5) That the food has dietary properties when such properties are of
no significant value or need in human nutrition.
(6) That a natural vitamin in a food is superior to an added or
synthetic vitamin or to differentiate in any way between vitamins
naturally present from those added.
[58 FR 2175, Jan. 6, 1993, as amended at 58 FR 2227, 2533, Jan. 6, 1993;
58 FR 17104, Apr. 1, 1993; 58 FR 17328-17331, Apr. 2, 1993; 58 FR 44048,
44076, Aug. 18, 1993; 58 FR 59363, Nov. 9, 1993; 58 FR 60109, Nov. 15,
1993; 59 FR 371, Jan. 4, 1994; 59 FR 62317, Dec. 5, 1994; 60 FR 17205,
Apr. 5, 1995; 60 FR 30788, June 12, 1995; 60 FR 67174, Dec. 28, 1995; 61
FR 8779, Mar. 5, 1996; 61 FR 14479, Apr. 2, 1996]
Effective Date Notes: 1. At 60 FR 67174, Dec. 28, 1995, in
Sec. 101.9, paragraph (c)(8)(iv) was revised, effective January 1, 1997.
For the convenience of the reader, the superseded text is set forth
below.
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(8) * * *
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units.
Vitamin C, 60 milligrams.
Calcium, 1.0 gram.
Iron, 18 milligrams.
Vitamin D, 400 International Units.
Vitamin E, 30 International Units.
Thiamin, 1.5 milligrams.
Riboflavin, 1.7 milligrams.
Niacin, 20 milligrams.
Vitamin B6, 2.0 milligrams.
Folate, 0.4 milligrams.
Vitamin B12, 6.0 micrograms.
Biotin, 0.3 milligram.
Pantothenic acid, 10 milligrams.
Phosphorus, 1.0 gram.
Iodine, 150 micrograms.
Magnesium, 400 milligrams.
Zinc, 15 milligrams.
Copper, 2.0 milligrams.
* * * * *
2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.9, in paragraph
(c)(8)(v) the entry which read ``Folate--Folacin'' was revised to read
as set forth above in the text, effective April 19, 1996.
[[Page 49]]